Basin, Emesis
The Emesis Basin is a shallow, kidney-shaped receptacle used in patient care settings to collect vomit or other fluids, or to hold instruments, swabs, and materials at the bedside. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FNY, regulated under 21 CFR 880.6730 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FNY
- Device Class
- FDA class 1
- Regulation Number
- 880.6730
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K832826 | AAP DOSIMETRY RELEASE OR BASIN SETS | Apr 23, 1984 | Substantially Equivalent | American Hospital Supply Corp. |
| K802538 | BASIN PACK | Oct 31, 1980 | Substantially Equivalent | Texas Medical Products, Inc. |
| K800440 | STERILE SPONGE BOWLS | Apr 29, 1980 | Substantially Equivalent | Premium Plastics, Inc. |
| K792625 | STERILIZATION PROCESS/PLACENTA BASIN | Jan 16, 1980 | Substantially Equivalent | Procter & Gamble Mfg. Co. |
| K771733 | 8 EMESIS BASIN | Sep 28, 1977 | Substantially Equivalent | Bemis Health Care |
| K760495 | BASIN, RECTANGULAR WASH | Nov 12, 1976 | Substantially Equivalent | Landmark Plastics |
| K760494 | BASIN, ROUND WASH | Nov 12, 1976 | Substantially Equivalent | Landmark Plastics |
| K760492 | BASIN, LARGE OR SMALL | Nov 12, 1976 | Substantially Equivalent | Landmark Plastics |
| K760085 | BASIN, STERILE (#3200) | Jul 20, 1976 | Substantially Equivalent | Concord Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 221 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 221 registration numbers. Click on an entry to view related FDA registrations.